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Prostaglandin Analog
Latanoprost for Glaucoma and Ocular Hypertension
Phase 1
Recruiting
Led By David S Friedman, MD, PhD, MPH
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 - 14 weeks
Summary
This trial is testing a novel contact lens drug delivery system with latanoprost to lower eye pressure. It will assess safety, tolerability, comfort & feasibility of the new method compared to eye drops.
Eligible Conditions
- Glaucoma
- Ocular Hypertension
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 - 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 - 14 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy assessed by changes in intraocular pressure - Phase B
Incidence of Treatment-Emergent Adverse Events as assessed by ocular infection, corneal epithelial defects, or cystoid macular edema - Phase A
Eye Infection
Secondary study objectives
Preliminary efficacy - Phase A: % change in IOP from baseline
Tolerability and comfort: questionnaire
Side effects data
From 2016 Phase 4 trial • 379 Patients • NCT020173271%
myocardial infarction
1%
hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumigan 0.01%
Monoprost
Lumigan 0.03% Unit Dose
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Latanoprost contact lensExperimental Treatment1 Intervention
The L-CL arm will have the drug-eluting latanoprost contact lens (L-CL) and a sham drop.
Group II: Topical LatanoprostPlacebo Group1 Intervention
The placebo arm will have a commercial contact lens with no drug with a nightly 0.005% latanoprost drop.
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Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
108 Previous Clinical Trials
13,003 Total Patients Enrolled
6 Trials studying Glaucoma
373 Patients Enrolled for Glaucoma
Harvard UniversityOTHER
233 Previous Clinical Trials
473,900 Total Patients Enrolled
David S Friedman, MD, PhD, MPHPrincipal InvestigatorMassachusetts Eye and Ear
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a complicated cataract surgery with loss of vitreous.You have had swelling in the back of your eye or inflammation of the middle layer of your eye in the past.The thickness of the cornea in the study eye is too thin (less than 500 μm) or too thick (more than 600 μm).You have had a bad reaction to latanoprost before.You can't wear a contact lens that fits like the one provided for the week-long trial period.You have an eye infection at the time of screening.You are taking oral carbonic anhydrase inhibitors.Your dosage of oral steroid is not consistent.You are currently using topical steroids.You have had surgery for eye pressure control.You have certain eye conditions like high eye pressure or specific types of glaucoma. If you have mild to moderate glaucoma, it's defined by a specific test result.You have a condition where the cornea in your eye is swollen or not working properly.You have been using latanoprost for less than 4 weeks before the screening.Your vision in the eye that's not being studied is very poor, at least 20/400 on the eye chart.You have taken certain types of medications that weaken the immune system within the last six months or plan to take them during the study.You have signs of fluid buildup in your eye's macula as seen on a special eye scan.You have an eye condition that would make it difficult to wear a contact lens, according to the doctor.You have used certain types of eye drops in the last month, or have been using latanoprost and it has not been stable for at least 4 weeks before the screening.You have new blood vessels growing in the back of your eye.You have a condition called rubeosis iridis in your eye.You have had a herpes infection in your eye or nearby area in the past.You have a problem with your eye that makes it difficult for the doctors to see and take pictures of it.You have had surgery to correct your vision.You are using latanoprost eye drops in one of your eyes, and it is effectively controlling the pressure inside your eye.
Research Study Groups:
This trial has the following groups:- Group 1: Topical Latanoprost
- Group 2: Latanoprost contact lens
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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